CMS and OSHA Release Interim Final Rules Regarding Mandatory COVID-19 Vaccination Requirements


On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) released separate, but complementary regulations that will establish COVID-19 vaccination requirements.  The Interim Final Rules and the related Emergency Temporary Standards (ETS) that they create will be officially published in the Federal Register on Friday, November 5, 2021, and will be effective immediately with vaccination required by January 4,, 2022.

The CMS rule applies to certain Medicare and Medicaid providers and suppliers who are regulated under specific health and safety standards known as Conditions of Participation.

The OSHA rule applies more broadly to all employers with 100 or more employees (large employers) and is not limited to companies that operate in the healthcare space.

While the two regulations are similar in nature,  to avoid confusion and facilitate proper understanding of the requirements of each rule and the impact that they may have on AOPA members they are reviewed separately below.

AOPA continues to encourage all of its members to ensure the health and well-being of their staff, patients, and members of the public through all means possible including COVID-19 vaccination.

AOPA will be performing a thorough review of both the CMS and OSHA Interim Final Rules and will develop and submit rule specific comments prior to the January 4, 2022, deadline.  We will also be providing additional resources to AOPA members in the coming weeks to ensure that you are adequately able to ensure compliance with the requirements of both rules.

CMS Interim Final Rule and Emergency Temporary Standard

When the White House initially announced plans to develop an ETS that would require COVID-19 vaccination for Medicare and Medicaid enrolled providers it was widely assumed that the ETS would apply to all that provide healthcare services to Medicare and Medicaid beneficiaries, including orthotic and prosthetic providers.  The release of the Interim Final Rule appears to have limited the application of the ETS to only the following provider and supplier types:

  • Ambulatory Surgical Centers (ASCs)
  • Hospices
  • Psychiatric residential treatment facilities (PRTFs)
  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities)
  • Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
  • Home Health Agencies (HHAs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services
  • Community Mental Health Centers (CMHCs)
  • Home Infusion Therapy (HIT) suppliers
  • Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)
  • End-Stage Renal Disease (ESRD) Facilities

Orthotic and Prosthetic providers are not included in the list of facilities subject to the CMS ETS and are therefore not directly subject to mandatory vaccination as a requirement for continued Medicare enrollment.  However, the impact of the CMS ETS on AOPA members remains significant as many of your organizations provide patient care within the walls of many of the covered provider types through privileging arrangements or contractual relationships.  The ETS is very clear that facility compliance extends beyond employees of the facility to include any entities that have access to their facility and patient population.  While AOPA members may not be directly impacted by the ETS, it is highly likely that any covered facilities will require your staff to be fully vaccinated to continue to provide services to their patients.

The CMS Fact Sheet regarding the Interim Final Rule which includes a comprehensive FAQ document may be accessed here.

OSHA Interim Final Rule and Emergency Temporary Standard

The Interim Final Rule and ETS released by OSHA is much broader in scope and applies to all employers in the United States that employ 100 or more employees.  The OSHA ETS is focused on promoting safety in the workplace and is not limited to any industry or profession.  Unlike the CMS ETS, the OSHA regulation provides an alternative to vaccination that would allow employees to undergo weekly COVID-19 testing and wear appropriate face coverings while at work.

The OSHA ETS creates a specific set of employer requirements that must be followed to remain in compliance with the regulations and ensure that workplaces remain as safe as possible. Enforcement of the OSHA regulatory requirements will primarily be through the provision of fines for non-compliance.

A helpful fact sheet including a summary of the employer requirements established by the OSHA ETS may be accessed here.

Questions regarding the Interim Final Rules or Emergency Temporary Standards may be directed to Joe McTernan at jmcternan@aopanet.org or Devon Bernard at dbernard@aopanet.org.